Study of an Investigational Pneumococcal Vaccine at Three Dose Levels in Healthy Adults
Pneumococcal InfectionsStreptococcus Pneumoniae Infections1 moreThis study is designed to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adult volunteers. Primary Objective: To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Observational Objective: To evaluate the immunogenicity of an investigational Pneumococcal vaccine.
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
PneumoniaPneumococcal Infections1 moreThis study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment. Primary Objective: To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Secondary Objective: To evaluate the immunogenicity of an investigational pneumococcal vaccine.
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm...
InfectionsStreptococcal1 moreThe purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of...
InfectionsStreptococcal1 moreThe purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Mexican infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined vaccine (Infanrix hexa) and rotavirus vaccine (Rotarix) in children during the first 6 months of age.
Effect of Two Versus Three Pneumococcal Conjugate Vaccinations
Streptococcus Pneumoniae InfectionTwo( 2) or three (3) instead of four vaccinations before the age of 6 months with pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal disease like meningitis, at least on the short term till 18-24 months of age. The current hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal transmission and induce no herd-immunity. Furthermore, antibody development and memory may benefit from carriage of vaccine type S. pneumoniae
Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants
Streptococcus PneumoniaeThe purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
InfectionsStreptococcal1 moreEvaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Among HIV-infected Adults...
Streptococcal PneumoniaHIV/AIDSHIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases. Pneumococcal vaccination is the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. HIV-infected subjects aged ≥ 18 years were recruited and divided into two age-matched groups: group 1 (subjects with CD4 T-cell counts ≥350 cells/µL) and group 2 (subjects with CD4 T-cell counts <350 cells/µL). Multiplex opsonophagocytic killing assay was used to compare immunogenicity after the immunization of 13-valent pneumococcal conjugate vaccine (PCV13).
PCV10 Immunogenicity Study Nepal 2015
Streptococcus PneumoniaeA single centre open-label, parallel group, randomised controlled trial, recruiting healthy Nepalese infants aged 40-60 days, who present to the immunisation clinic at Patan Hospital, Kathmandu, Nepal, randomised to receive a 10-valent pneumococcal conjugate vaccine (PCV10) at either; 6+10 weeks and 9 months OR 6+14 weeks and 9 months The study will enroll 152 healthy Nepalese infants in each treatment arm (304 in total). Demographic and clinical data will be collected on an electronic case report form to allow monitoring remotely. Participants will receive the study vaccine according to their allocated treatment arm in addition to their other routine vaccines. The investigators will collect 3 blood samples for analysis of serum antibody responses to the PCV10 vaccine serotypes throughout infancy (see Table 1). The data collected will be analysed in order to determine whether the 6+10 schedule is non-inferior to the 6+14 schedule in generating immune responses against the vaccine serotypes above the ≥0•35μg/mL threshold. These data will then be used to inform decision-making around augmenting the currently recommended 6+14 schedule to a 6+10 schedule in Nepal. The investigators will collect a nasopharyngeal swab at 2 time points to look at carriage of pneumococcus over time and to assess differences between the 2 groups. This is of critical importance because much of the programmatic impact of PCV is ultimately conferred by reductions in carriage at the community level and indirect effects resulting from that nasopharyngeal (NP) protection.
Costa Rica Epidemiological Study on S. Pneumoniae
Streptococcus PneumoniaeStreptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia and pneumococcal meningitis among infants and children worldwide. Knowledge of the epidemiology of pneumococcal disease is essential to assess the potential usefulness of pneumococcal disease usefulness of pneumococcal conjugate immunization. There is a paucity of information regarding pneumococcal disease burden in children in Latin America. Most studies are based on passive microbiology laboratory surveillance that does not capture all invasive disease, thus underestimating the true disease burden. Data from an active surveillance is available from an specific region in Costa Rica, before introduction of universal vaccination with PCV-7. On January 2009, PCV-7 was introduce into the universal vaccination program for all children born after or on September 2008 using a 3+1 regimen therefore there is a possibility to analyze the benefits of the introduction of this vaccine into the universal immunization program. The only effectiveness data from Latin America have been published from Uruguay where a significant decline in the incidence of pneumonias and meningitis was observed following the introduction of PCV-7. This was associated with an increment of serotypes 19A, 1,5 and 7F. Uruguay modify PCV-7 to PCV-13. In Costa Rica on August 2011, PCV-7 was changed for PCV 13. This study will provide information regarding the impact of PCV-7 and PCV-13.